PsychosisNCT02202694
Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan
A study testing Culturally Adapted Cognitive behavior therapy in people with Psychosis, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial summary
Aim: To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in Pakistan. Design: Randomized Control Trial Setting: Psychiatry Departments of General Hospitals in Karachi. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Culturally Adapted Cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- Mar 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Psychosis established by clinician using ICD10 criteria.
- Individuals aged between 18-65.
- Should not have learning disability.
- Resident of Karachi.
- Participant is able to give informed written consent
Who cannot join
- Severe illness which may affect capacity or markedly affect their ability to participate in interview, e.g. very thought disordered or distressed by symptoms.
- Severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence according to ICD10 RDC).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan
Aim:
To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in Pakistan.
Design:
Randomized Control Trial
Setting:
Psychiatry Departments of General Hospitals in Karachi.
Participants:
A total of 36 patients with a diagnosis of psychotic disorder will be randomized to a psychological intervention or treatment as usual arm.
Intervention:
Culturally Adapted Cognitive Behavioral Therapy (CBT)
Outcome measure:
Positive and Negative syndrome scale (PANSS) Psychotic symptoms Rating Scales (PSYRATS)
Read the detailed description
The purpose of the study is to test the feasibility of culturally adaptive CBT for Psychosis in Pakistan
Primary :
-To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in Pakistan.
Secondary:
- To assess fidelity of culturally-adapted CBT for psychosis.
- To further modify CaCBTp in accordance with findings of feasibility study
The Participants will be recruited from psychiatric department of different hospitals.They will be randomly divided into two groups; intervention group and treatment-as-usual group. A total of thirtysix participants will be recruited in the feasibility study and divided equally into two arms. This will ensure that, even after loss to follow-up, the investigators will have at least 12 subjects per group for analysis (FDA guidance http://www.fda.gov/cder/guidance/5356fnl.pdf. Randomization will be carried out by the on offsite statistician . This will provide a reliable geographically remote service. For intervention group twelve sessions of CaCBTp will be delivered by trained research clinician for a period of three months. Participants in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested Participants will be offered CaCBTp.
- Conditions
- Psychosis
- Being tested
- Culturally Adapted Cognitive behavior therapy
- Keywords
- CBT, Psychosis, cultural adaptation, Pakistan
- Medical subject headings
- Psychotic Disorders, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Adapted Cognitive behavior therapyBehavioural
Also called Psychosocial intervention
This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Culturally Adapted Cognitive Behavior Therapy Receives: Behavioral: Culturally Adapted Cognitive behavior therapy |
| Control | No intervention | Patients who will be randomized to the "treatment as usual" arm will receive routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative syndrome scale (PANSS)
The PANSS is a structured clinical interview consisting of 30 items designed to assess severity of symptoms over the past week on a 7-point scale.
Measured: up to 6 months
Secondary outcomes (4)
Psychotic Symptom Rating Scales (PSYRATS)
The PSYRATS consists of 17 items that focus on auditory hallucinations and delusions experienced over the past week.
Measured: Baseline ,3 months & 6 months
Insight rating scale
Assesses Improvement in insight
Measured: Baseline ,3 months & 6 months
Calgary Depression Scale for Schizophrenia
This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia.
Measured: Baseline ,3 months & 6 months
Short Explanatory Model Interview
used to elicit beliefs of mental illness
Measured: Baseline ,3 months & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startMar 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, Dow University of Health Sciences, Abbasi Shaheed Hospital
- Responsible party
- Sponsor
- Investigators
- Nusrat Husain, MD, Principal investigator, Pakistan Institute of Learning and Living, University of ManchesterImran Chaudhry, MD, Principal investigator, University of ManchesterFarooq Naeem, MRCPsych, Principal investigator, Pakistan Institute of Learning and Living, University of SouthamptonRaza ur Rehman, FCPS, Principal investigator, Dow University of Health SciencesAjmal Kazmi, Principal investigator, Pakistan Institute of Living and LearningMunir Hamirani, FCPS, Principal investigator, Abbasi Shaheed Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202694
- Sponsor's protocol ID
- CBT-PSY-01
- Status last verified
- Jul 2014
- First submitted
- 15 Apr 2014
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Husain MO, Chaudhry IB, Mehmood N, Rehman RU, Kazmi A, Hamirani M, Kiran T, Bukhsh A, Bassett P, Husain MI, Naeem F, Husain N. Pilot randomised controlled trial of culturally adapted cognitive behavior therapy for psychosis (CaCBTp) in Pakistan. BMC Health Serv Res. 2017 Dec 6;17(1):808. doi: 10.1186/s12913-017-2740-z.
PubMed 29207980
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Culturally Adapted Cognitive Behavior Therapy for Psychosis in Pakistan
- ClinicalTrials.gov ID
- NCT02202694
- Acronym / sponsor ID
- CBT-PSY-01
- Conditions
- Psychosis
- Keywords
- CBT, Psychosis, cultural adaptation, Pakistan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- University of Manchester, Dow University of Health Sciences, Abbasi Shaheed Hospital
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim:
To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in Pakistan.
Design:
Randomized Control Trial
Setting:
Psychiatry Departments of General Hospitals in Karachi.
Participants:
A total of 36 patients with a diagnosis of psychotic disorder will be randomized to a psychological intervention or treatment as usual arm.
Intervention:
Culturally Adapted Cognitive Behavioral Therapy (CBT)
Outcome measure:
Positive and Negative syndrome scale (PANSS) Psychotic symptoms Rating Scales (PSYRATS)
Detailed description
The purpose of the study is to test the feasibility of culturally adaptive CBT for Psychosis in Pakistan
Primary :
-To assess the feasibility of application of culturally-adapted CBT (CaCBTp) for use in Pakistan.
Secondary:
- To assess fidelity of culturally-adapted CBT for psychosis.
- To further modify CaCBTp in accordance with findings of feasibility study
The Participants will be recruited from psychiatric department of different hospitals.They will be randomly divided into two groups; intervention group and treatment-as-usual group. A total of thirtysix participants will be recruited in the feasibility study and divided equally into two arms. This will ensure that, even after loss to follow-up, the investigators will have at least 12 subjects per group for analysis (FDA guidance http://www.fda.gov/cder/guidance/5356fnl.pdf. Randomization will be carried out by the on offsite statistician . This will provide a reliable geographically remote service. For intervention group twelve sessions of CaCBTp will be delivered by trained research clinician for a period of three months. Participants in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested Participants will be offered CaCBTp.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Culturally Adapted Cognitive behavior therapyCulturally Adapted Cognitive Behavior Therapy |
| Control | No intervention | –Patients who will be randomized to the "treatment as usual" arm will receive routine care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Psychosis established by clinician using ICD10 criteria.
- Individuals aged between 18-65.
- Should not have learning disability.
- Resident of Karachi.
- Participant is able to give informed written consent
Key exclusion criteria (2 listed)
- Severe illness which may affect capacity or markedly affect their ability to participate in interview, e.g. very thought disordered or distressed by symptoms.
- Severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence according to ICD10 RDC).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally Adapted Cognitive behavior therapyAlso: Psychosocial interventionThis 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component | Behavioural | Intervention |
Primary outcome
Positive and Negative syndrome scale (PANSS)
Time frame: up to 6 months
The PANSS is a structured clinical interview consisting of 30 items designed to assess severity of symptoms over the past week on a 7-point scale.
4 secondary outcomes
Psychotic Symptom Rating Scales (PSYRATS)
Time frame: Baseline ,3 months & 6 months
Insight rating scale
Time frame: Baseline ,3 months & 6 months
Calgary Depression Scale for Schizophrenia
Time frame: Baseline ,3 months & 6 months
Short Explanatory Model Interview
Time frame: Baseline ,3 months & 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Derived from this study: PubMed 29207980Husain MO, Chaudhry IB, Mehmood N, Rehman RU, Kazmi A, Hamirani M, Kiran T, Bukhsh A, Bassett P, Husain MI, Naeem F, Husain N. Pilot randomised controlled trial of culturally adapted cognitive behavior therapy for psychosis (CaCBTp) in Pakistan. BMC Health Serv Res. 2017 Dec 6;17(1):808. doi: 10.1186/s12913-017-2740-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nusrat Husain, MD principal investigator
Pakistan Institute of Learning and Living, University of Manchester
Imran Chaudhry, MD principal investigator
University of Manchester
Farooq Naeem, MRCPsych principal investigator
Pakistan Institute of Learning and Living, University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Adapted Cognitive behavior therapy in people with Psychosis, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative syndrome scale (PANSS) (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02202694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.